ALPHA 1 LUNG DISEASE MARKET ANALYSIS

The Alpha 1 Lung Disease Market size is expected to reach US$ 16.78 billion by 2030, from US$ 4.99 billion in 2023, at a CAGR of 18.9% during the forecast period. Alpha 1 lung disease is a genetic disorder that causes lung and liver disease. It is caused by a lack of alpha-1 antitrypsin protein in the blood. The market is driven by rising prevalence of COPD, increasing awareness of lung diseases and new product launches. The Alpha 1 Lung Disease Market is segmented into disease type, treatment type, and route of administration, distribution channel, and region. By disease type, Chronic Obstructive Pulmonary Disease (COPD) accounts for the largest market share due to the high prevalence and increasing risk factors like smoking.

Alpha 1 Lung Disease Market Regional Insights

• North America is expected to be the largest market for Alpha 1 Lung Disease during the forecast period, accounting for over 38.5% of the market share in 2023. The growth of the market in North America is attributed to high diagnosis rates, favorable reimbursement policies, and presence of key players.
• Europe is expected to be the second-largest market for Alpha 1 Lung Disease, accounting for over 32.2% of the market share in 2023. The growth of the market in Europe is attributed to rising COPD prevalence, government initiatives, and product launches.
• Asia Pacific is expected to be the fastest-growing market for Alpha 1 Lung Disease, showcasing a CAGR of over 15.3% during the forecast period. The growth of the market in Asia Pacific is attributed to the growing healthcare expenditure, rising COPD burden, and improving diagnosis rates.

Analyst’s Views: The global alpha 1 lung disease market is expected to grow steadily driven by increasing diagnosis rates and awareness about the disease. North America currently dominates the market owing to high healthcare spending and developed healthcare infrastructure in countries like the U.S. However, Asia Pacific is likely to witness the fastest growth fueled by rising healthcare expenditure and an expanding patient pool in China and India. The market has a huge unmet need as alpha 1 lung disease is often underdiagnosed. Advancements in diagnostic tests and greater screening efforts could aid in diagnosis of number of cases. Furthermore, the development of gene therapy as a possible cure presents a massive opportunity for drug makers in the long run. However, high research costs involved in developing novel therapies may deter pharmaceutical companies. Regulatory issues could pose a challenge with varying approval norms across regions. Lack of disease-specific clinical guidelines is another restraint due to limited understanding of the condition. Insurance coverage too remains inadequate for high-cost treatments in many countries. Overall, growing public-private initiatives to spread awareness, increasing collaborations between industry and academia, and emerging new screening guidelines are expected to fuel the market growth over the next decade.

Figure 1. Alpha 1 Lung Disease Market Share (%), by Region, 2023

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Alpha 1 Lung Disease Market Drivers

• Rising Prevalence of COPD Globally: The increasing prevalence of COPD around the world is a major factor driving the Alpha 1 lung disease market growth. According to the World Health Organization (WHO), over 250 million people suffer from COPD worldwide.
• Increasing Diagnosis Rates: Diagnosis rates for alpha-1 lung disease have improved in recent years due to growing awareness and improved screening methods. This is expected to boost the market growth during the forecast period.
• New Product Launches and Approvals: Key players are focused on launching new and advanced therapies for alpha-1 lung disease. For instance, in November 2022, Grifols, S.A., a leader in plasma-derived medicines and innovative diagnostic solutions, announced that its AlphaID At Home Genetic Health Risk Service, the first-ever free direct-to-consumer program in the U.S. to screen for genetic risk of alpha1-antitrypsin deficiency (alpha-1).
• Strong Pipeline of Drugs: The alpha-1 lung disease pipeline is strong with over 40 candidates in different stages of development. This is expected to drive the market growth.

Alpha 1 Lung Disease Market Opportunities

• Increasing Awareness Programs: Organizations are undertaking initiatives to spread awareness about alpha-1 lung disease. This is expected to improve diagnosis rates and boost growth.
• Growth in Emerging Markets: High unmet needs in emerging economies due to lack of awareness and infrastructure provide significant growth opportunities for market players
• Development of Oral Therapies: Most current alpha-1 therapies are injectable. The launch of oral drugs will improve patient compliance and open up new avenues.
• Gene Therapy: Researchers are focused on developing gene therapy for treating alpha-1 lung disease. Success in this area can revolutionize the market landscape.

Alpha 1 Lung Disease Market Trends

• Advancements in Augmentation Therapy: Players are developing improved augmentation therapies with higher purity levels and efficiency. This can increase adoption of augmentation therapy among patients.
• Combination Therapies: Combining alpha-1 therapies with other COPD drugs such as bronchodilators are gaining traction.
• Increasing Online Pharmacies: Sales through online pharmacies are rising due to benefits such as discounts, home delivery, and ease of ordering
• Use of Big Data: Big data analytics enables better understanding of disease patterns and supports the development of personalized medicine

Alpha 1 Lung Disease Market Restraints

• High Cost of Therapy: The high cost of alpha-1 therapies such as augmentation therapy hinders market growth, especially in developing regions such as Asia Pacific
• Adverse Effects: Side effects, such as nausea, associated with alpha-1 drugs can limit their adoption among patients
• Low Awareness Levels: Lack of disease awareness among the general population has resulted in low diagnosis rates.

Figure 2. Global Alpha 1 Lung Disease Market Share (%), By Disease Type, 2023

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Recent Developments

New Product Launches & Approvals

• On September 21, 2023, Krystal Biotech Inc., a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug Application (IND) for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).
• On May 16, 2023, Kamada Ltd., a commercial stage global biopharmaceutical company, announced that Swissmedic, the national authorization and supervisory authority for drugs and medical products has granted marketing authorization for Glassia [Alpha-1 Proteinase Inhibitor (Human)] in Switzerland for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary Alpha-1 antitrypsin deficiency (AATD).
• On May 11, 2023, Grifols, S.A., a leader in plasma-derived medicines and innovative diagnostic solutions, announced it has launched its AlphaID At Home Genetic Health Risk Service (AlphaID At Home), the first-ever free direct-to-consumer program in the U.S. to screen for the genetic risk of alpha1-antitrypsin deficiency (alpha-1).
• In October 2022, Mereo BioPharma Group plc., a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966) as a treatment for AATD-associated lung disease.
• In July 2021, Grifols, S.A., a leading producer of plasma-derived medicines, and OrphanPacific, Inc., a provider of drugs for rare diseases and disorders in Japan, announced the beginning of the commercialization of Lynspad (intravenous infusion 1000mg), an alpha-1 proteinase inhibitor to treat severe alpha-1 antitrypsin deficiency (AATD) in the country.

Acquisition, Collaborations, and Partnerships

• On September 26, 2023, Alfasigma S.p.A, a leading pharmaceutical company, announced the acquisition of Intercept Pharmaceuticals, Inc., a leading biopharmaceutical company in rare and serious liver diseases, to expand Alfasigma S.p.A’s gastrointestinal and hepatology portfolio and its presence in the U.S. market.
• In July 2022, Vertex Pharmaceuticals Incorporated, a pharmaceutical company, announced the acquisition of ViaCyte, a privately-held biotechnology company for alpha-1 lung disease for potential cure of lung diseases
• In December 2022, GSK plc, a pharmaceutical company, announced a collaboration with Wave Life Sciences Ltd., a clinical-stage genetic medicines company, to advance oligonucleotide therapeutics, including Wave Life Sciences Ltd.’s preclinical RNA editing Programme targeting alpha-1 antitrypsin deficiency (AATD), WVE-006. The discovery collaboration has an initial four-year research term. It combines GSK plc’s unique insights from human genetics, as well as its global development and commercial capabilities, with Wave Life Sciences Ltd’s proprietary discovery and drug development platform, PRISMTM.
• In October 2020, Takeda Pharmaceutical Company Limited, a pharmaceutical company, announced a collaboration with Arrowhead Pharmaceuticals Inc., a pharmaceutical company, to develop ARO-AAT, a Phase 2 investigational RNA interference (RNAi) therapy in development to treat alpha-1 antitrypsin-associated liver disease (AATLD). ARO-AAT is a potential first-in-class therapy designed to reduce the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression.

Top Companies in the Alpha 1 Lung Disease Market

• AstraZeneca
• Boehringer Ingelheim International GmbH
• Hoffmann-La Roche Ltd
• Novartis AG
• Pfizer Inc.
• Merck & Co., Inc.,
• Bristol-Myers Squibb
• Takeda Pharmaceutical Company Limited.
• CSL Behring
• Vertex Pharmaceuticals Incorporated
• Amgen Inc.
• Sanofi
• GSK plc
• Gilead Sciences, Inc.
• AbbVie Inc.
• Regeneron Pharmaceuticals Inc.

Definition: The Alpha 1 Lung Disease Market refers to the market and domain focusing on diagnosis, treatment, and management of conditions caused due to alpha-1 antitrypsin (AAT) deficiency, a common inherited genetic disorder. It primarily consists of therapies and drugs used for addressing alpha-1 lung diseases like Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis, liver cirrhosis, and bronchiectasis. Key therapies include alpha-1 proteinase inhibitor augmentation treatment, gene therapy, lung transplantation, and supportive therapies like oxygen treatment and bronchodilators. The market comprises pharmaceutical companies, medical device makers, hospitals, specialty clinics, research organizations, distributors, and other entities involved in the development and commercialization of therapies for alpha-1 lung disease patients. Growth is driven by increasing prevalence of alpha-1 lung diseases, growing diagnosis rates, strong research pipelines, new product launches, and rising awareness. North America and Europe are the largest markets due to high awareness about lung diseases and favorable reimbursement.